Beta Cell Function in (Pre) Type 1 Diabetes
This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Beta Cell Function in (Pre) Type 1 Diabetes|
- The systematic and simultaneous determination of markers of functional beta cell mass and immune status allows stratification according to the stage of the pathogenic process rather than according to a late metabolic consequence of this process [ Time Frame: 48 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
No Intervention: FDR of type 1 diabetes patients receiving glucose 20%
First Degree Relatives of diabetes type 1 patient with a high, intermedian or low risk (accoring to the criteria of the protocol), for developing diabetes type 1.
Drug: glucose 20%
maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion: with a maintenance dose computed at 5- to 10-minute intervals
This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes. These criteria may help to determine the time point and type of prevention may contribute to the composition of homogeneous groups of study subjects (based on residual beta cell mass, homogeneous risk of beta cell destruction during intervention) and may lead to the identification of functional markers that could be used as surrogate endpoints. This may reduce the number of subjects needed to treat as well as the follow-up time necessary to study significant effects of the test substance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800085
|Universitair Ziekenhuis Antwerpen|
|Brussels, Belgium, 1090|
|Gent, Belgium, 9000|
|Leuven, Belgium, 3000|
|Principal Investigator:||katelijn Decochez, MD PhD||UZ Brussels|